PAIN RELIEVER- aspirin 81 mg tablet, delayed release 
Health Pharma USA LLC

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Pain Reliever - Aspirin Delayed Release Tablets, 81 mg

Drug Facts

Active Ingredients (in each tablet)

Aspirin 81 mg (NSAID)*

*nonsteroidal anti-inflammatory drug

Purpose

Pain reliever

Uses

Warnings

Reye's syndrome:

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert:

Aspirin may cause a severe allergic reaction which may include:

  • hives
  • shock
  • facial swelling
  • asthma (wheezing)

Stomach bleeding warning:

  • This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:
  • are age 60 or older
  • have had stomach ulcers or bleeding problems
  • take a blood thinning (anticoagulant) or steroid drug
  • take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]
  • have 3 or more alcoholic drinks every day while using this product
  • take more or for a longer time than directed

Do not use

  • if you are allergic to aspirin or any other pain reliever/fever reducer

Ask a doctor before use if

  • you have asthma
  • stomach bleeding warning applies to you
  • you have a history of stomach problems, such as heartburn
  • you have high blood pressure, heart disease, liver cirrhosis or kidney disease
  • you are taking a diuretic

Ask a doctor or pharmacist before use if you are

  • taking a prescription drug for diabetes, gout, or arthritis
  • under a doctor's care for any serious condition
  • taking any other drug

Stop use and ask a doctor if

  • you experience any of the following signs of stomach bleeding:
  • feel faint
  • have bloody or black stools
  • vomit blood
  • have stomach pain that does not get better
  • an allergic reaction occurs.

   Seek medical help right away.

  • ringing in the ears or loss of hearing occurs
  • pain gets worse or lasts for more than 10 days
  • fever gets worse or lasts for more than 3 days
  • redness or swelling present in the painful area
  • new symptoms occur

These could be sign of a serious condition

If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Other information

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

Starch, Povidone, Microcrystalline cellulose, Crosscarmellose Sodium, Methacrylic acid copolymer and ethyl acrylate co-polymer, Triethyl citrate, Talc, Fumed Silica, Titanium Dioxide, D&C Yellow #10, FD&C Yellow#6

Questions or comments?

Call toll free 1-844-832-1138

Monday through Friday 9AM – 5PM EST

PRINCIPAL DISPLAY PANEL

See New Warnings Information

Compare to Bayer ®Low Dose Aspirin active ingredients*

*This product is not manufactured or distributed by Bayer HealthCare LLC., owner of the registered trademark Bayer ®Low Dose Aspirin.

Aspirin Delayed Release Tablets, 81 mg

Aspirin

PAIN RELIEVER 
aspirin 81 mg tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71679-104
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN81 mg
Inactive Ingredients
Ingredient NameStrength
STARCH, CORN (UNII: O8232NY3SJ)  
POVIDONE (UNII: FZ989GH94E)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
TALC (UNII: 7SEV7J4R1U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
Product Characteristics
ColoryellowScoreno score
ShapeROUNDSize7mm
FlavorImprint Code A1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71679-104-101000 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2022
2NDC:71679-104-05500 in 1 BOTTLE; Type 0: Not a Combination Product01/21/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01301/21/2022
Labeler - Health Pharma USA LLC (080804485)
Establishment
NameAddressID/FEIBusiness Operations
Health Pharma USA LLC080804485manufacture(71679-104)

Revised: 10/2023
Document Id: 08d4eee2-dde1-f367-e063-6394a90a3326
Set id: d60aed37-3a9e-46d1-e053-2995a90a1d1f
Version: 3
Effective Time: 20231020
 
Health Pharma USA LLC